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Hecolin in seniors aged over 65 years

NCT02189603Phase 4

Key facts

Status: Completed
Start: Jun 2014
Primary completion: Dec 2015
Countries: 1
Modality: Recombinant Protein Vaccines

Drugs: HEV 239
Conditions: hepatitis E (HEV)

Overview

Phase 4, open-label trial of HEV 239 in hepatitis E (HEV) (3 arms). Primary endpoint: Number of Participants with Serious and Non-Serious Adverse Events. Started Jun 2014; status: completed.

Design

3 arms

Study design: Non-randomizedOpen-label

Senior group(over 65 years old)-HE
Seniors (>65), Seronegative: Hecolin at 0, 1, 6 months
Younger groups(16-65 years old)
Adults (16-65): Hecolin at 0, 1, 6 months
Senior group(over 65 years old)-Cont
Seniors (>65), Seropositive: No intervention

Who it enrols

Healthy subjects aged 16 years or older, residing in the study region for the next 7 months, with no history of Hepatitis E. Seniors (>65) were stratified by anti-HEV IgG serostatus.

Endpoints

Primary

Number of Participants with Serious and Non-Serious Adverse EventsMonth 0-7

Secondary

anti-HEV IgG seropositive rateMonth 7
Geometric Mean Titer of anti-HEV IgGMonth 7

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